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HI-TECH PHARMACAL CO. v. U.S. FOOD AND DRUG ADMIN.

Civil Action No. 08-01495 (JDB).

587 F.Supp.2d 1 (2008)

HI-TECH PHARMACAL CO., INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendants, and Apotex, Inc., Intervenor-Defendant.

United States District Court, District of Columbia.

October 10, 2008.

Attorney(s) appearing for the Case

James Philip Ellison, Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

Drake S. Cutini, Department of Justice Office of Consumer Litigation, Steven Y. Bressler, U.S. Department of Justice, Washington, DC, for Defendant.

Carmen Mercedes Shepard, Kate Cumming Beardsley Buc & Beardsley, Washington, DC, for Intervenor Defendant.

MEMORANDUM OPINION

JOHN D. BATES, District Judge.

Plaintiff Hi-Tech Pharmacal Co., Inc. ("Hi-Tech") brings this action pursuant to the Administrative Procedures Act ("APA") asserting a statutory right under the Drug Price Competition and Patent Term Restoration Act of 1984 (known as the "Hatch-Waxman Act"), as amended by the Medicare Modernization Act of 2003, to a 180-day period of marketing exclusivity for the generic version of the branded drug...

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